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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K142515
Device Name MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway, Mailcode D02
Malvern,  PA  19355
Applicant Contact Cordell L. Fields
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway, Mailcode D02
Malvern,  PA  19355
Correspondent Contact Cordell L. Fields
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/08/2014
Decision Date 10/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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